Note: This document contains side effect information about lamotrigine. Some dosage forms listed on this page may not apply to the brand name Subvenite.

Summary

Common side effects of Subvenite include: ataxia, skin rash, headache, insomnia, and nausea. Other side effects include: infection, dyspepsia, abnormal gait, constipation, and drowsiness. Continue reading for a comprehensive list of adverse effects.

Applies to lamotrigine: oral tablets conventional, oral tablets extended-release film-coated, oral tablets for oral suspension, oral tablets orally disintegrating.

Side effects include:

Immediate-release lamotrigine (the active ingredient contained in Subvenite) as adjunctive anticonvulsant therapy in adults: dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, pharyngitis, rash. Additional adverse effects reported in children: vomiting, infection, fever, accidental injury, diarrhea, abdominal pain, tremor.

Extended-release lamotrigine as adjunctive anticonvulsant therapy in adults and children ≥13 years of age: dizziness, tremor/intention tremor, vomiting, diplopia.

Immediate-release lamotrigine in adults with bipolar disorder: nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, xerostomia.

For Healthcare Professionals

Applies to lamotrigine: oral tablet, oral tablet disintegrating, oral tablet dispersible, oral tablet extended release.

General

The more commonly reported adverse reactions have included dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, and rash.^[Ref]

Immunologic

In cases of hemophagocytic lymphohistiocytosis (HLH), patients have presented with signs of systemic inflammation (fever, rash, hepatosplenomegaly, and organ system dysfunction) and blood dyscrasias. Symptoms have been reported within 8 to 24 days.^[Ref]

Postmarketing reports: Progressive immunosuppression, Lupus-like reaction, vasculitis, drug reaction with eosinophilia and systemic symptoms (DRESS), hemophagocytic lymphohistiocytosis (HLH)^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction, chills, malaise^[Ref]

Nervous system

Very common (10% or more): Dizziness (38%), headache (29%), ataxia (22%), somnolence (14%)

Common (1% to 10%): Seizure exacerbation, incoordination, insomnia, tremor, speech disorder, amnesia, hypoesthesia, pain, gait abnormality, vertigo, dyspraxia, confusion, paresthesia

Uncommon (0.1% to 1%): Akathisia, aphasia, central nervous system depression, dysarthria, dyskinesia, hyperkinesia, hypertonia, movement disorder, myoclonus, sudden unexplained death in Epilepsy (SUDEP)

Rare (less than 0.1%): Choreoathetosis, dystonia, extrapyramidal syndrome, faintness, grand mal seizures, hemiplegia, hyperalgesia, hyperesthesia, hypokinesia, hypotonia, neuralgia, muscle spasm, neuralgia, paralysis, peripheral neuritis

Very rare (less than 0.01%): Muscle spasm, paralysis, peripheral neuritis

Postmarketing reports: Exacerbation of Parkinsonian symptoms in patients with pre-existing Parkinson's disease, tics^[Ref]

Sudden unexplained death in epilepsy (SUDEP) was reported in 20 of 4700 patients with epilepsy during premarketing development. While this exceeds the expected rate in healthy populations, it is within the range for patients with epilepsy.^[Ref]

Psychiatric

Common (1% to 10%): Depression, anxiety, irritability, disturbance of concentration, emotional lability, abnormal thinking, nervousness

Uncommon (0.1% to 1%): Apathy, euphoria, hallucinations, hostility, depersonalization, memory decrease, mind racing, panic attack, paranoid reaction, personality disorder, psychosis, sleep disorder, stupor, suicidal ideation

Rare (less than 0.1%): Delirium, delusions, dysphoria, manic depression reaction, neurosis

Postmarketing reports: Aggression, nightmares^[Ref]

Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior. Pooled analyses of 199 placebo-controlled clinical trials of 11 different AEDs (monotherapy or adjunctive therapy) showed twice the risk compared with placebo patients; an estimated incidence of 0.43% (n=27,863) in AED-treated patients compared to 0.24% (n=16,029) in placebo. The median treatment duration was 12 weeks. There were 4 suicides in AED-treated patients (placebo=0). The risk of suicidal thoughts or behavior was considered similar among the drugs studied despite their varying mechanisms of action suggesting the risk applies to all AEDs used for any indication. Additionally, the risk did not vary substantially by age.^[Ref]

Ocular

Very common (10% or more): Diplopia (28%), blurred vision (16%)

Common (1% to 10%): Vision abnormality, nystagmus, photosensitivity, amblyopia

Uncommon (0.1% to 1%): Abnormality of accommodation, conjunctivitis, dry eyes, photophobia

Rare (less than 0.1%): Lacrimation disorder, oscillopsia, ptosis, strabismus, uveitis, visual field defect^[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (20%), nausea (19%), diarrhea (10%)

Common (1% to 10%): Abdominal pain, vomiting, dyspepsia, constipation, anorexia, dry mouth, rectal hemorrhage, peptic ulcer, flatulence

Uncommon (0.1% to 1%): Dysphagia, eructation, gastritis, gingivitis, increased appetite, increased salivation, mouth ulceration

Rare (less than 0.1%): Gastrointestinal hemorrhage, glossitis, gum hemorrhage, gum hyperplasia, hematemesis, hemorrhagic colitis, melena, stomach ulcer, stomatitis, tongue edema

Very rare (less than 0.01%): Pancreatitis, esophagitis^[Ref]

Respiratory

Very common (10% or more): Rhinitis (14%)

Common (1% to 10%): Pharyngitis, increased cough, epistaxis, dyspnea, bronchitis, sinusitis, bronchospasm

Uncommon (0.1% to 1%): Yawn

Rare (less than 0.1%): Hiccup, hyperventilation

Postmarketing reports: Apnea^[Ref]

Dermatologic

In adult patients (n=3348), serious rash associated with hospitalization and discontinuation was reported in 0.3% of patients in premarketing epilepsy trials. In bipolar trials, serious rash occurred in 0.08% of patients receiving this drug as initial monotherapy and 0.13% of patients receiving this drug as adjunctive therapy. In worldwide postmarketing experience, rash-related death has been reported, but the numbers are too few to permit a precise estimate of rate.

In a prospectively followed cohort of pediatric patients 2 to 17 years old, the incidence of serious rash was approximately 0.3% to 0.8%. In a prospectively followed cohort of patients 2 to 16 years old (n=1983), 1 rash-related death occurred in a patient with epilepsy taking this drug as adjunctive therapy.

Evidence has show the inclusion of valproate in a multidrug regimen increases the risk of serious, potentially life-threatening rash in both adult and pediatric patients. In pediatric patients who used valproate concomitantly for epilepsy, 1.2% (6 of 482) experienced a serious rash (placebo=0.6%). In adults, 1% of patients of patients receiving this drug in combination with valproate (n=584) experienced a rash (placebo=0.16%).^[Ref]

Very common (10% or more): Rash (14%)

Common (1% to 10%): Contact dermatitis, dry skin, sweating, eczema, pruritus

Uncommon (0.1% to 1%): Acne, alopecia, hirsutism, maculopapular rash, skin discoloration, urticaria

Rare (less than 0.1%): Angioedema, erythema, exfoliative dermatitis, fungal dermatitis, herpes zoster, leukoderma, multiforme erythema, petechial rash, pustular rash, Stevens-Johnson syndrome, vesiculobullous rash^[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, vaginitis, amenorrhea, libido increase, urinary tract infection (both male and female), urinary frequency

Uncommon (0.1% to 1%): Libido decreased, abnormal ejaculation, hematuria, impotence, menorrhagia, polyuria, urinary incontinence

Rare (less than 0.1%): Anorgasmia, breast abscess, breast neoplasm, creatinine increase, cystitis, dysuria, epididymitis, female lactation, nocturia, urinary retention, urinary urgency^[Ref]

Other

Very common (10% or more): Fever (15%), accidental injury (14%)

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Ear pain, taste perversion, tinnitus

Rare (less than 0.1%): Alcohol intolerance, deafness, taste loss, parosmia, taste loss^[Ref]

Metabolic

Common (1% to 10%): Weight decrease, weight gain, peripheral edema, facial edema

Rare (less than 0.1%): Bilirubinemia, general edema, gamma glutamyl transpeptidase increase, hyperglycemia^[Ref]

Musculoskeletal

Common (1% to 10%): Neck pain, arthralgia, myalgia, decreased reflexes, back pain, increased reflexes, asthenia

Uncommon (0.1% to 1%): Arthritis, leg cramps, myasthenia, twitching

Rare (less than 0.1%): Bursitis, muscle atrophy, pathological fracture, tendinous contracture

Postmarketing reports: Rhabdomyolysis (among patients experiencing hypersensitivity reactions)^[Ref]

Cardiovascular

Common (1% to 10%): Chest pain, migraine

Uncommon (0.1% to 1%): Flushing, hot flashes, hypertension, palpitations, postural hypotension, syncope, tachycardia, vasodilation^[Ref]

Hematologic

Uncommon (0.1% to 1%): Leukopenia

Rare (less than 0.1%): Anemia, eosinophilia, fibrin decrease, fibrinogen decrease, iron deficiency anemia, leukocytosis, lymphocytosis, macrocytic anemia, ecchymosis, thrombocytopenia

Postmarketing reports: Agranulocytosis, hemolytic anemia, lymphadenopathy not associated with hypersensitivity disorder^[Ref]

Hepatic

Common (1% to 10%): Lymphadenopathy

Uncommon (0.1% to 1%): Liver function tests abnormal, aspartate transaminase (AST) increased

Rare (less than 0.1%): Hepatitis, alanine transaminase ALT) increased, acute kidney failure, kidney failure, kidney pain^[Ref]